Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020325
Company: KENVUE BRANDS
Company: KENVUE BRANDS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PEPCID AC | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | None | Yes | No |
| PEPCID AC | FAMOTIDINE | 20MG | TABLET;ORAL | Over-the-counter | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/28/1995 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/12/2026 | SUPPL-45 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020325Orig1s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/020325Orig1s045ltr.pdf | |
| 12/14/2023 | SUPPL-43 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020325Orig1s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020325Orig1s043ltr.pdf | |
| 12/15/2022 | SUPPL-41 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020325Orig1s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020325Orig1s041ltr.pdf | |
| 02/18/2022 | SUPPL-37 | Labeling-Container/Carton Labels |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020325Orig1s037lbl.pdf | |
| 04/09/2019 | SUPPL-33 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020325Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020325Orig1s033ltr.pdf | |
| 08/01/2016 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/08/2016 | SUPPL-30 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020325Orig1s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020325Orig1s030ltr.pdf | |
| 05/05/2016 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/09/2015 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/06/2015 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/20/2015 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/2013 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/11/2012 | SUPPL-24 | Labeling-Container/Carton Labels |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020325Orig1s024Lbl.pdf | |
| 06/09/2006 | SUPPL-19 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020325s019LTR.pdf |
| 10/27/2004 | SUPPL-17 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20325s017,20801s010,20902s007,20958s010ltr.pdf |
| 09/23/2003 | SUPPL-15 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20325se2-015_pepcid_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20325se2-015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020325s015TOC.html | |
| 03/01/2002 | SUPPL-13 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20325s13ltr.pdf |
| 04/05/2000 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/10/2000 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/1998 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/15/1998 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/09/1998 | SUPPL-7 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 09/26/1997 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/23/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/03/1996 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20325s3ltr.pdf |
| 10/02/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1996 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/12/2026 | SUPPL-45 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020325Orig1s045lbl.pdf | |
| 12/14/2023 | SUPPL-43 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020325Orig1s043lbl.pdf | |
| 12/15/2022 | SUPPL-41 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020325Orig1s041lbl.pdf | |
| 02/18/2022 | SUPPL-37 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020325Orig1s037lbl.pdf | |
| 04/09/2019 | SUPPL-33 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020325Orig1s033lbl.pdf | |
| 06/08/2016 | SUPPL-30 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020325Orig1s030lbl.pdf | |
| 10/11/2012 | SUPPL-24 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020325Orig1s024Lbl.pdf | |
| 09/23/2003 | SUPPL-15 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20325se2-015_pepcid_lbl.pdf |
PEPCID AC
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 20MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Over-the-counter | No | 215766 | ANNORA PHARMA |
| FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Over-the-counter | No | 216030 | ASCENT PHARMS INC |
| FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Over-the-counter | No | 206531 | AUROBINDO PHARMA |
| FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Over-the-counter | No | 218003 | CONTRACT PHARMACAL |
| FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Over-the-counter | No | 077367 | DR REDDYS LABS LTD |
| FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Over-the-counter | No | 090837 | GLENMARK PHARMS |
| FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Over-the-counter | No | 218461 | GRAVITI PHARMS |
| FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Over-the-counter | No | 217543 | MARKSANS PHARMA |
| FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Over-the-counter | No | 077351 | PERRIGO R AND D |
| FAMOTIDINE | FAMOTIDINE | 20MG | TABLET;ORAL | Over-the-counter | No | 215822 | VKT PHARMA |
| PEPCID AC | FAMOTIDINE | 20MG | TABLET;ORAL | Over-the-counter | Yes | 020325 | KENVUE BRANDS |
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 10MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| FAMOTIDINE | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | No | 215766 | ANNORA PHARMA |
| FAMOTIDINE | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | No | 216030 | ASCENT PHARMS INC |
| FAMOTIDINE | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | No | 206531 | AUROBINDO PHARMA |
| FAMOTIDINE | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | No | 218003 | CONTRACT PHARMACAL |
| FAMOTIDINE | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | No | 077367 | DR REDDYS LABS LTD |
| FAMOTIDINE | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | No | 077146 | GLENMARK PHARMS |
| FAMOTIDINE | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | No | 218461 | GRAVITI PHARMS |
| FAMOTIDINE | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | No | 217543 | MARKSANS PHARMA |
| FAMOTIDINE | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | No | 075512 | P AND L |
| FAMOTIDINE | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | No | 075400 | PERRIGO |
| FAMOTIDINE | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | No | 215822 | VKT PHARMA |
| PEPCID AC | FAMOTIDINE | 10MG | TABLET;ORAL | Over-the-counter | Yes | 020325 | KENVUE BRANDS |